The device and method in the present invention relate to delivery of medicine to the middle and/or inner ear and evacuation of fluid, if any, located in the tympanic cavity. The device and the method can be used, for example, for treatment and/or prevention of various ear-related ailments, such as acute otitis media.
It is frequently desirable to deliver various types of medicine into the tympanic cavity. Such medicine can be directed at treating ailments of the middle as well as the inner ear. For example, medically effective amounts of antibiotic and/or anti-inflammatory drug(s) can be delivered through the tympanic membrane to treat middle ear infections. Currently, delivery of the drugs into the tympanic cavity is usually done when the tympanic membrane has ruptured or the patient has a previously-inserted tube in the membrane, that is, non-surgical delivery of medicine to the tympanic cavity is usually done only when there is an existing perforation in the tympanic membrane, through which the medicine is delivered. The majority of the patients, however, do not have an existing perforation through which medicine can be delivered; consequently, such procedure is not available to them.
Alternatively, a physician can use a syringe to inject medicine through the tympanic membrane. However, this procedure can be dangerous for several reasons. First, the tympanic cavity houses a variety of vulnerable structures, such as the malleus, incus, stapes, facial nerve, and in some cases carotid artery. An accidental contact with any of these structures can result in adverse effects that range from pain and severe bleeding (in case of a punctured carotid artery or branches of the internal jugular vein) to permanent disability, such as hearing loss.
Any incisions and/or perforations of the tympanic membrane in the posterosuperior and anterosuperior quadrants are highly discouraged because the most vulnerable structures located in the tympanic cavity are positioned proximately behind these two quadrants. Consequently, incisions and/or perforations of the tympanic membrane are usually performed in the posteroinferior and anteroinferior quadrants. Further, incisions and/or perforations made in the posteroinferior and anteroinferior quadrants must also be done with extreme care, and accidental penetration more than a minimal depth beyond the normal physiological position of the tympanic membrane can cause severe injuries. Because the physician must insert the needle in a tiny area and with minimal penetration, the margin for error is very small. Consequently, incisions and/or penetrations of the tympanic membrane in children are usually performed under general anesthesia, to avoid accidental over-penetration or an unwanted penetration in a wrong location (for example, a perforation in the posterosuperior quadrant or contact with the ear canal) as a result of the child's inability to remain stationary during the procedure.
This invention offers a novel way of safely delivering desired amounts of medicine into, as well as aspirating fluid from, the tympanic cavity. The invention allows evacuation of fluid from the tympanic cavity, delivery of medicine into the tympanic cavity, and/or biopsy of the tympanic membrane by making a minute perforation in the membrane. Furthermore, the invention allows the procedure to be performed quickly, safely and without general anesthesia by limiting the depth and location of the penetration on the tympanic membrane. The invention also allows for safe removal of fluid accumulated in the tympanic cavity and subsequent analysis of the fluid. Such analysis, for example, may include a test for the presence of bacteria and a determination of the type of bacteria present. Consequently, the invention will reduce the need for systemic treatment of ailments related to middle and inner ear in patients who do not have a perforated tympanic membrane, especially in children.
One of the major deficiencies of the current devices is the potential to make contact with crucial physiological structures behind the membrane, injuring the patient. This potential for injury is amplified in young patients. Although an adult patient is likely to comply with a request to remain stationary while the physician injects him with a four-inch needle, a child is likely to ignore such request.